1
Abstract of dissertation entitled
“An evidence-based protocol of gum chewing in
preventing postoperative paralytic ileus in adult
patients after abdominal surgeries”
Submitted by
Li Fong Ming
for the degree of Master of Nursing
at The University of Hong Kong
in July 2015
2
Postoperative paralytic ileus is a very common complication following
with abdominal surgeries. It has been affecting a lot of patients in the local
setting. It is also a difficult situation for the health care providers.
In many studies, the use of chewing gum has been shown to be an
effective method for the prevention of postoperative ileus. It is significant in
helping patients to resume their bowel function in an easy and harmless way. It
is hopeful that this innovation can help more patients in the local setting.
In this regard, this translational research aims at developing an evidence-
based protocol on using chewing gum in the prevention of postoperative
paralytic ileus for adult patients after abdominal surgeries. A systematic search
for relevant literatures was performed with the use of three electronic
databases. Five relevant studies were found. Critical appraisal on the relevant
studies was conducted. The level of evidence extracted from the studies was
graded according to the Scottish Intercollegiate Guidelines Network (SIGN) and
were synthesized to establish the protocol for patients in the proposed setting.
The implementation potential of the protocol was assessed in terms of the
transferability, feasibility, and cost benefit ratio. An implementation and
evaluation plan was established for comprehensive evidenced-based protocol
development.
The successful implementation of the protocol will be beneficial for the
patients undergoing abdominal surgeries as it may prevent them from ileus,
minimizing their suffering and hasten their recovery.
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“An evidence-based protocol of gum chewing in
preventing postoperative paralytic ileus in adult
patients after abdominal surgeries”
by
Li Fong Ming
B. Nurs. H. K. U.
A dissertation submitted in partial fulfillment of the requirements for
the Degree of Master of Nursing
at The University of Hong Kong
July 2015
4
Declaration
I declare that this thesis represents my own work, except where due
acknowledgement is made, and that it has not been previously included in a
thesis, dissertation on report submitted to this University or to any other
institution for a degree, diploma or other qualification.
Signed
Li Fong Ming
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Acknowledgement
I would like to express my sincere gratitude towards Dr. William Li, my
dissertation supervisor, for his professional advice and unreserved support in
helping me to complete this dissertation. I would also like to thank the teachers
in this master study that enlightened my vision for the future.
I would also grateful to my family, friends, classmates and my fellow
colleagues who shared my happiness and encouraged me throughout my whole
master study.
6
Table of content
Chapter 1: Introduction-----------------------------------------------------------------------9
1.1 Background----------------------------------------------------------------------------------9
1.2 Affirming needs---------------------------------------------------------------------------10
1.3 Significance and objectives-------------------------------------------------------------11
Chapter 2: Critical appraisal ---------------------------------------------------------------14
2.1 Search and appraisal strategies -------------------------------------------------------14
2.2 Results --------------------------------------------------------------------------------------15
2.3 Summary and synthesis-----------------------------------------------------------------17
Chapter 3: Implementation potential -----------------------------------------------------22
3.1 Target setting and target audience----------------------------------------------------22
3.2 Transferability of the findings ---------------------------------------------------------22
3.2.1 Target setting and audience-------------------------------------------------22
3.2.2 Philosophy of care-------------------------------------------------------------23
3.2.3 Number of people benefiting------------------------------------------------24
3.3 Feasibility ----------------------------------------------------------------------------------25
3.4 Cost- benefit ratio of the proposed protocol----------------------------------------25
3.4.1 Potential risk of the innovation---------------------------------------------25
3.4.2 Potential benefit of the innovation ----------------------------------------26
3.4.3 Cost- benefit analysis---------------------------------------------------------26
Chapter 4: Developing evidence-based practice protocol-----------------------------28
4.1 Title------------------------------------------------------------------------------------------28
4.2 Intended users of the proposed protocol--------------------------------------------28
4.3 Purpose of proposed protocol ---------------------------------------------------------28
4.4 Target population of the proposed protocol----------------------------------------28
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4.5 Rating scheme of the protocol ---------------------------------------------------------28
4.6 Recommendations------------------------------------------------------------------------29
Chapter 5: Implementation plan -----------------------------------------------------------33
5.1 Identification of stakeholders----------------------------------------------------------33
5.2 Planning ------------------------------------------------------------------------------------34
5.3 Sustaining the change--------------------------------------------------------------------35
Chapter 6: Pilot study test-------------------------------------------------------------------36
6.1 Objectives of the pilot-testing plan----------------------------------------------------36
6.2 Study design and sample recruitment------------------------------------------------36
6.3 Data collection-----------------------------------------------------------------------------37
6.4 Data analysis-------------------------------------------------------------------------------38
6.5 Evaluation----------------------------------------------------------------------------------38
Chapter 7: Evaluation plan ------------------------------------------------------------------40
7.1 Identifying outcomes to be achieved -------------------------------------------------40
7.2 Nature and number of patients involved --------------------------------------------41
7.3 Data collection and analysis------------------------------------------------------------42
7.4 Effective criteria for the protocol------------------------------------------------------44
Chapter 8: Conclusion------------------------------------------------------------------------46
8.1 Conclusion----------------------------------------------------------------------------------46
Reference list-----------------------------------------------------------------------------------79
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List of appendix
Appendix 1: Table of evidence--------------------------------------------------------------48
Appendix 2: SIGN Checklist -----------------------------------------------------------------53
Appendix 2.1 SIGN Checklist 1-----------------------------------------------------54
Appendix 2.2 SIGN Checklist 2 ----------------------------------------------------57
Appendix 2.3 SIGN Checklist 3 ----------------------------------------------------60
Appendix 2.4 SIGN Checklist 4 ----------------------------------------------------63
Appendix 2.5 SIGN Checklist 5 ----------------------------------------------------66
Appendix 3 Search history ------------------------------------------------------------------69
Appendix 4 PRISMA 2009 Flow Diagram-------------------------------------------------71
Appendix 5 Timeline--------------------------------------------------------------------------72
Appendix 6 Cost -------------------------------------------------------------------------------73
Appendix 7 SIGN-------------------------------------------------------------------------------74
Appendix 8 Evaluation form for patients-------------------------------------------------75
Appendix 9 Evaluation form for health care providers--------------------------------76
Appendix 10 decision flow chart-----------------------------------------------------------77
Appendix 11 the chewing gum guideline/protocol ------------------------------------78
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Chapter 1 Introduction
1.1 Background
Postoperative care (Nicholas, 1941) plays an important role in nursing for
patients’ recovery after surgery. Along the recovery process, ileus has been a
great challenge, which is a common complication in patients who have
undergone abdominal surgeries. Postoperative ileus (POI) is defined as “ A
temporary impairment in gastrointestinal motility following surgery” (Artinyan,
2008). After surgery, affecting by anesthesia or other drugs effect, complete bed
rest, and continuously keeping nil by mouth, the GI system is likely to “switching
off” for a certain period of time. For patients who have difficulties in “switching
on” again so as to resume the normal GI function, ileus may have been occurred.
It causes trouble to both patients and the medical staff. It also adds burden to the
medical system of the community.
Patients’ suffering
For patients, POI is a huge suffering combining with pain, vomiting and
bloating (Quatromoni, 1980). It often let patients down by destroying their prior
expectation to the operation. POI prolongs patients’ postoperative recovery and
could lead to further health problems such as nutritional and psychological
problems.
Nurses’ challenge
For nurses, POI is a difficult situation to deal with. POI increases nurses’
workload by requiring close monitoring. Also, active intervention to cases of
severe ileus, intensive explanation of condition to patients and their relative, are
all hardship to the frontline staff. POI challenges nurses with the nurse-patient
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communication, symptom controlling for patients, maintenance of patients’
quality of life and also the long way of their rehabilitation.
System’s challenge
For the medical system, POI increases medical expenditure of the
community by prolonged hospitalization of patients. Additional treatment,
medication and care are all needed for POI. It stressed the medical system and
the staff thus threatens the medical service (Bisanz, 2008).
1.2 Affirming needs
Insufficient current guidelines
My setting is a surgical unit at a local government hospital. Traditional
postoperative care has been practiced for many years. For cases of POI, medical
staff in my local setting tends to make use of nasogastric tube insertion in most
of the time (Sagar, 1992). It is to drain out excessive excretion and gas from the
patients’ stomach so as to promote their comfort and gut movement in a certain
extent. However, the insertion of NG tube always causes another way of suffering
to the patients. Normally, physiotherapy is relied to be the main treatment for
POI. By mobilizing the patients, it is believed to be useful in stimulating the body
functioning including the GI system. In reality, physiotherapy has its limit to
postoperative patients. It is not suitable for ill cases. Wound bleeding, wound
pain, and the risks of fall are all obstacles for physiotherapy. In other words,
although physiotherapy is still the golden treatment for POI in the setting, it is
not always applicable to all POI cases. On the other hand, it can be harmful if
implementing inappropriately.
Gap in current practice
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The treatment for POI is generally conservative in the local setting. POI is
treated as a normal complication. Under the current guidelines, medical staff has
little preparation for the occurrence of POI since it is not a complication that
happens absolutely in every single case. In most of the cases, medical staff would
just deal with it when it happens. The readiness for managing POI is limited, as it
is not directly fatal, however, it is unpleasant and traumatic. There is always an
old saying of “ Prevention better than cure”, and this should also be applied to
POI. To deal with POI, there is a variation in care between units and even
between staff. In some units, early feeding after surgery is advised to be beneficial
in resuming patients’ GI function (Seenu, 1995). In other unit, early ambulation is
suggested. There are also units suggesting massage to abdomen could stimulate
gut movement. There is no conclusive management method for POI and it is
always hard to judge which is better or worse. There is no evidence- based
guideline, which tells nurses how to manage POI systemically. There is no
structural practice but medical staff tends to manage POI by their own experience
or basing on senior staff’s experience. The practice gap is significant. Need for a
change
Managing the problem of POI should be in high priority in the surgical
department. It is still a very common complication with limited prevention and
education available in the settings. POI is known to be one of the most torturing
postoperative experiences of patients. It is a clinical problem created additional
to the primary illness, which made the disease process become complex.
Moreover, in terms of prevalence and severity, POI has never been behind any
other postoperative complication such as wound infection or chest infection.
However, when management protocols for wound infection and chest infection
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are available and keep on developing, it is still a blank page for POI. When POI
occurs among patients, it always takes a long way to have it resolved. It keeps
demanding on patients, nurses and even the medical service without significant
breakthrough in recent years.
1.3 Significance and objectives
Significance
Over the decade, gum chewing has been studied for its effectiveness in
preventing POI in many western countries. There have been a lot of clinical trials
done to prove the significance of gum chewing. There are also studies done by
researchers to learn about the mechanism of gum chewing in stimulating gut
movement. In most of the researches, gum chewing has been positively
commented on its effectiveness. In some western hospitals, it is even practiced
by nurses under evidence-based guideline. Unlike physiotherapy, gum chewing
is known to be a safe treatment with no complication to implement after surgery.
There is no reason of not adding gum chewing into the postoperative care
protocol in terms of POI prevention.
In the local setting, however, gum chewing for POI still has much room of
development in the surgical aspect. New innovation is often difficult to
introduced unless it arrives at the most critical moment. It tends to be
conservative and passive in making changes in the local setting. Therefore, gum-
chewing protocol is still not yet been approved to used.
Objectives
Understanding the possible advantage of gum chewing with balancing its
cost effectiveness, gum chewing is considered as a feasible innovation to support.
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By designing an evidenced- based guideline for gum chewing in POI prevention, it
is believed that the patients, the nurses and the medical system would be
benefited from it. With evidenced- based gum chewing protocol, patients would
have a great chance in preventing POI. This allows an additional aid on top of the
traditional care in helping patients with the return of bowel function. This would
possibly minimize their postoperative suffering and improving comfort. Also,
this innovation would provide a clear guideline for nurses, helping nurses to have
consistent practice in preventing POI of the patients, thus increasing the quality
of care. The gum chewing guideline would probably raise the awareness of the
prevention of POI among the medical staff. The prevention of POI would
eventually reduce the stress to front line nurses by reducing the occurrence of it.
To the medical services, burden in caring complicated postoperative cases would
also be minimized with less POI cases. Confidence towards the medical service
would be increased with the rapid recovery of patients. This would also improve
the whole medical system by encouraging evidence-based practice. All in all, the
chewing gum protocol is worth to implement. It is supported by many previous
studies and it is transferable. It should be the time of bringing its benefit to
patients in the local setting.
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Chapter 2 Critical appraisal
2.1 Search and appraisal strategies
In this dissertation, three electronic databases have been used. They are
the PubMed, the CINAHL and the Mosby’s nursing consult. For search keywords,
“chewing gum”, “sham feeding”, “postoperative ileus”, “bowel movement” and
“postoperative care” are used in different combination throughout the search
process.
Inclusion and exclusion criteria
There are several inclusion criteria for the search. To be selected, subjects
have to be aged 18 or above, who has undergone abdominal surgery under
general anesthesia for any indication. They have to be able to provide written
informed consent. They also have to be able to chew gum. Cases of emergency
surgery, postoperative admission to ICU or requiring postoperative intubation,
subjects with previous bowel surgery, complaints of chronic constipation,
history of inflammatory bowel diseases, thyroid diseases, intestinal obstruction,
abdominal radiation or neoadjuvant chemotherapy are all excluded in the
selection.
Summary of searching
In total, there are five different papers selected from the three databases.
More details of the five studies are summarized in form of table of evidence
attached in appendix 1. SIGN is selected as the appraisal tool in this dissertation.
It is a methodology checklist to rate the quality of the research papers. In this
paper, SIGN checklist for controlled trials would be used since all selected papers
are using randomized control trials. Every selected paper would be assessed for
15
its internal validity and overall quality by SIGN checklist. Rates of quality would
be given to each study at the end. For the selected five papers, they all rated
acceptable quality with one paper got high quality through the assessment.
Individual comment was made to each paper in the checklists. All SIGN checklists
would be attached in appendix 2 in this paper. For grades of recommendations,
please kindly refer to the next chapter of this dissertation.
2.2 Results
The period of search is from the December of 2013 to May of 2014.
PubMed
From PubMed, 145 citations were found after keyword search; 11 citations
were chosen after further screening of titles and abstracts; 2 citations were
chosen after reading the full test; 1 more citation was chosen after checking
reference and removing duplicates. At the end, 3 citations were selected from
PubMed.
CINAHL
From CINAHL, 285 citations were found after keyword search; 19
citations were chosen after further screening of titles and abstracts; 1 citation
was chosen after reading the full test; no more citation was chosen after
checking. At the end, only 1 citation was selected from CINAHL.
Mosby’s
From Mosby’s, 43 citations were found after keyword search; 12 citations
were chosen after further screening of titles and abstracts; 3 citations were
chosen after reading the full test. At the end, 1 citation was selected after
16
removing all duplicates from the previous search results of the other two
databases.
Summary of data
All search history is available in appendix 3 in table form. There are totally
five RCTs selected in this paper whereas three from the PubMed, one from the
CINAHL and one from the Mosby’s. Among the five studies, two of them are from
Turkey, and the other is from India, California and Korea accordingly. The five
papers were published between 2006-2013 with all of them presented in
English. The sample size of the five studies varies from 34 to 152 participants.
Abdominal surgeries with any indication are selected with fulfillment of the
inclusion criteria and exclusion criteria. Gender of subjects is not specifically
selected.
All the five papers support the possibility of chewing gum to be
implemented for POI prevention. They all show significant data in proving the
effectiveness of chewing gum in hastening bowel motility. They also share
similar inclusion and exclusion criteria. Effects from extrinsic variables are
successfully minimized through the selection in the five papers. They share
similar protocol of chewing gum implementation as well with all of them
choosing sugarless gum in the trails. However, the schedule of gum chewing
varies between the five studies. Moreover, they have similar outcome
measurement with all of them focusing on the response from the bowel including
bowel sound and the passage of flatus. Lastly, they all use mean for their
statistical comparison between intervention and control groups. They all present
a shorter time, in term of mean, in having the return of bowel function for the
gum-chewing intervention groups.
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2.3 Summary and synthesis
Summary
In summary, the five papers share no diversity of conclusion. According to
their results, patients in their intervention group, who have gum-chewing
regime, generally experienced an earlier return of bowel moment. In terms of
time measuring in hours, they all show a shorter period of time to have the first
flatus and bowel sound heard after surgery from the intervention group
comparing to the control group that received only standard normal care. The
presence of the first flatus and bowel sound after surgery does imply the absence
of POI. This shows how the chewing gum works in getting rid of POI by
motivating the gut movement of the patients. Although there is small variation in
methodology such as blinding, randomization procedures, and chewing gum
protocol, the conclusion of the five papers are still consistent.
Synthesis
It is believed that gum-chewing protocol for POI prevention is applicable
to implement in my local government setting. Making use of the five selected
papers, several recommendations are made for the innovation and the target
group.
Choice of gum
For the innovation, sugarless gum should be used. All the five papers have
selected sugarless gum with obvious reasons. Sugarless gum is suitable for the
largest number of target group including those who have limitation in taking
sugar such as the diabetic patients. It is suggested to choose chewing gum with
18
the simplest component so as to minimize any risk of allergy or unpleasant
reaction in patients.
Timing for implementation
For the timing of implementing the chewing gum protocol, which is the
time to let patients start gum chewing, two out of the five papers suggested to
start on postoperative day one while one paper suggested 6 hours after surgery
and the other papers did not specify the start time. It is believed that
postoperative day one would be a good timing to start the gum chewing protocol.
It is because at the day of surgery, patients may fail to return full conscious level.
Gum chewing requires a person’s self-initiation in the movement of chewing. Role
of nurses and target patients
For nurses, their job may be administrating the gum and help with the
time keeping in schedule. Patients need to initiate the chewing procedure on
their own effort so it is better not choosing the time right after the surgery but
postoperative day one. It allows the target patients enough time to rest and
wake. It prevents the insufficient chewing due to fatigue or accidental
swallowing of gum due to unconsciousness. Postoperative day one is believed to
be the best timing to start the gum chewing protocol. It is commonly suggested
in the five papers that, the sooner to start with the protocol, the earlier patients
could resume their gut moment through the simulation from chewing. As long as
having the target patients have their conscious level return normal, the chewing
gum protocol should not be delayed.
Chewing gum regime schedule
In terms of the chewing gum regime schedule, the five papers had the
largest diversity in it, despite sharing almost everything in common. Four out of
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the five papers suggested having gum chewing three times a day with different
duration while one paper suggested eight times a day with chewing gum two-
hourly from 8am to midnight every day. According to the result from the papers,
the one suggested chewing gum two-hourly did produce in the shortest time for
first flatus and first bowel sound with 6.07 hours and 3.92 hours compared to the
other four papers. From the results of all papers, it can be roughly concluded that
the more gum patients chew, the less time to spend time in resuming their bowel
movement. The time need for the first bowel sound heard and the first flatus
noticed decreased from the increased amount of gum chewing. However,
considering having gum chewing two-hourly from 8am to the midnight, there are
totally eight times of chewing to patients and also eight times of administration
and time management of chewing gum from nurses. Although it produces the
best result of gut motility after surgery, it can be a demand to both patients and
nurses. From the beginning, it is wished to relieve nurses and patients’ burden
from POI, however, the frequent gum chewing become another stress to the both
side. Therefore, in order to balance a suitable regime for gum chewing,
administrating three times a day suggested by the majority of papers should be
considered. For the papers suggested three times a day for gum chewing, they
suggested each time for chewing from30 min to 60min. Considering having gum
chewing for 60min did not resulted in a shorter time for the first flatus from the
paper, 30min of gum chewing is recommended.
Target group
For the target group, patients who have undergone abdominal surgeries
are believed to be a large group with large effect size beneficial from the chewing
gum protocol. Abdominal surgery is a very common operation. Many surgical
20
illnesses would need involvement of abdominal surgery along the disease
process. In terms of inclusion criteria, it is known to be a flexible selection
according to the five papers. Restriction in age at 18 or above is reasonable,
while the ability of providing inform consent and chewing gum are also
reasonably specified for this kind of study. Comparing the five chosen papers,
they commonly have no strict criteria for the selection of target group unless it is
a complex abdominal surgery with potential difficulty in implementing the gum
chewing protocol. The exclusion criteria are also reasonable without significant
avoidant of unwanted results. They all stressed that patients who had previous
bowel problem should be excluded in the study since it may not reflect the
effectiveness of gum chewing in reality. Those previous bowel problems may
yield false results. For cases of emergency surgery and postop admission and
intubation to be excluded, it is also reasonable, as it is a very common exclusion
criterion in many other medical studies. Therefore, the common exclusion
criteria from the five papers are appreciated and should be make use of.
Conclusion of synthesis
All in all, summarizing from the five papers, it is recommended that
making use of sugarless gum, by first administrating gum chewing at
postoperative day one for the target patients, with three times a day and 30min
of chewing in each section would possibly yield the best result balancing the pros
and cons in all aspects. For the selection of subjects, all the five papers are
appreciated in their reasonable inclusion and exclusion criteria. There is no
intention of them to yield results on their preference. The degree of
randomization is also satisfactory.
21
According to the five papers, the chewing gum protocol will be continued
until the return of target patients’ gut motility unless they are no longer suitable
to follow the protocol along the way. The length of follow up would be the time
when the first flatus passes and the first bowel sound heard. Prevention of POI is
achieved with the active stimulation of the return of gut moment. Patients would
be possibly beneficial from it without experiencing the torture from POI. In this
paper, it is hopefully to illustrate the effectiveness of the chewing gum protocol
for patients who have undergone abdominal surgeries, in prevention of POI and
to hasten the return of their bowel function, comparing with the patients from
abdominal surgeries, who receive traditional postoperative care.
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Chapter 3: Implementation potential
In this chapter, implementation potential of using chewing gum to
prevent POI will be discussed. Discussion will be made on the target setting, the
target audience, transferability of findings, feasibility and the cost-benefit
analysis. An evidence based practice protocol will be proposed in the later part,
illustrating with recommendations.
3.1 Target setting and target audience
Target setting
The target setting will be the surgical wards from a local government
hospital at the Kowloon west cluster. There are five surgical wards at the target
hospital. There are totally 200 beds and the yearly admission rate is around
3000 patients. There are roughly 300 patients receive abdominal surgeries every
year. The selected ward provides surgical service to population mainly living at
Kwai Chung, Tsing Yi and Mei Foo with around 0.56million of residents, which is
around 8% of the total Hong Kong population (Population Census, 2011).
Target audience
The target audience will be the patients who admitted to the target
setting. They have to be aged 18 or above with any indication which have them
undergone abdominal operation under general anesthesia.
3.2 Transferability of the findings
3.2.1 Target setting and audience
Target setting
23
All selected studies were conducted in surgical wards with similar setting
with the target setting.
Target audience
Subjects in the selected studies share similar characteristics with the
target audience including age, disease and intervention. They are aged 18 or
above with major operation done under general anesthesia. Thirdly, as both the
subject from the studies and the target audience have to be undergone
abdominal surgeries, they all face similar risk of postoperative ileus as it has a
high incidence rate among this kind of operation. Moreover, all the selected
studies were conducted in cities, which share similar economic and social
background with the target setting.
3.2.2 The philosophy of care
The philosophy of care underlying the new innovation fits to the target
setting. Prevention better than cure is one important belief of the target hospital.
It is always hoped by the target hospital that, to help patient by taking
Preventing measure could let them get rid of suffering. Besides, the target
hospital also believes in humanism. It encouraged all kind of non-invasive
measure before the need of invasive intervention. It believes that minimizing the
suffering of patients along their hospitalization is one important mission. The
use of chewing gum is a new kind of preventive treatment for POI. It is also a
non-invasive measure, which is harmless to patients. This innovation fit the
philosophy of care of the target hospital.
After comparison between the target setting and the selected studies, it is
found that the new innovation is fit to the target setting with high level of
transferability from the findings.
24
3.2.3Number of people benefiting
A sufficient amount of surgical patients will be beneficial from the new
innovation. According to the statistic of the target hospital, there are roughly 250
surgical admissions every month with around 10% of them have the need of
abdominal surgeries. Most of them face difficulties in having return of bowel
function mainly due to drug effect and prolong bed rest. For rough estimation, by
implementing the new innovation, it could help around 300 patients to prevent
POI and to enhance bowel motility annually in the target setting.
The new innovation would take 58 weeks for implementation and
evaluation. A committee would be formed for launching the innovation. The
committee would be responsible for planning, training, implementing, data
collecting and evaluation. Regular meeting would be held for problem solving
and quality control. Timetable of launching the innovation is attached to
appendix 5.
3.3 Feasibility
In the target hospital, it encourages evidence-based practice with the
setting up of a Journal club. Having previous trails of new innovation supported
by the hospital, it is believe the chewing gum protocol would have the freedom to
try and the freedom to stop if anything goes wrong. The Journal provides funding
to be applied for new program. With funding, it is feasible to carry out staff
development and buying equipment such as sugarless gum. It is also feasible to
employ extra staff to take up the additional workload from the implementation
of new innovation. All nurses from the target ward are familiar with
25
postoperative care so it is believed that it would be easy for them to carry out the
chewing gum protocol since it requires mainly basic care.
Both department manager and ward manager are supportive to new
innovation. However, gaining consensus from ward nurses would be the biggest
challenge. Although administrating chewing gum is similar to administrating
medicines, which requires minimal extra technique, however, monitoring
patients under the chewing gum protocol could add workload to ward staff. This
could lead to a moderate amount of interference to current staff function.
Besides, it is always difficult to make changes with agreement from all staff. Some
nurses may be reluctant to new practice while some may feel difficult to comply
with new protocol. From observation, nurses from the target ward share
different degree of ability in adaptation. The problem of consensus is obvious for
the chewing gum protocol.
The evaluation would be divided into two parts: protocol effectiveness
and feedback from personnel. Patients’ report of first flatus and first bowel
sound heard by nurses are the evaluation tools to use for protocol effectiveness.
All record will be kept with time record. All data from target audience will be
collected and analyzed to draw a report of effectiveness of the chewing gum
protocol. Besides, two sets of questionnaires would be distributed to patients
and nurses. For nurses, feedback on the program and guideline would be
collected for future modification of the protocol. For patients, their satisfaction
level would be assessed. The program committee would be responsible to work
on the evaluation at the later part of the program.
26
3.4 Cost- benefit ratio of the proposed protocol
3.4.1 Potential risk of the innovation
The chewing gum protocol appears to have minimal risk to patients. In
the selected studies, most of them stated the harmless use of chewing gum is the
biggest advantage of it. Only a few of exceptional cases reported unfavorable
condition after using the chewing gum, including gastric discomfort and
accidentally swallow of gum.
3.4.2 Potential benefit of the innovation
The chewing gum protocol brings more benefit than risks to patients. All
selected studies show scientifically significant result of preventing POI by using
chewing gum. They all prove it having a shorter time to first bowel movement and
flatus. Chewing gum is cheap and user-friendly. It is easy to administrated by
nurses and easy to use by patients. By using sugarless gum, it has no worry in
increasing patients’ blood glucose level. Since the gum would not go along the
digestive system, it also prevents the possible ileus causing by eating. It
stimulates the gut movement by sham feeding.
3.4.3Cost-benefit analysis
In terms of material cost, it is another advantage of the chewing gum
protocol. Sugarless gum is cheap in. Staff training is needed though it doesn’t
need a lot since the protocol does not require complicated techniques. The
biggest cost comes to the employment of extra staff to share additional
workload. The set up and operational cost is illustrated in appendix 6. In terms of
non-material cost, it would be the stress from staff. When it reaches to an
unacceptable level of stress, turnover of staff would be another cost. Nurses need
time for adaptation and training. Along the adaptation process, support from
27
colleagues and manager are important to overcome difficulties. To deal with staff
stress, the committee and the manager can hold briefing session at the beginning
of every shift. This could facilitate information exchange and create
psychological support to staff. The program committee should actively help with
problem solving and encounter difficulties from staff. After that, the non-material
cost can become non-material gains, which are the encouragement of evidence-
based study and the supporting atmosphere at ward, which enhance staff
morale.
28
Chapter 4: Developing evidence-based practice protocol
4.1 Title
An evidence-based protocol of gum chewing in preventing postoperative
paralytic ileus (POI) in adult patients after abdominal surgeries.
4.2 Intended users of the proposed protocol
Surgical nurses who provide postoperative care to patients who are at risk of
POI.
4.3 Purpose of proposed protocol
1. To provide an evidence-based protocol of best practice on using chewing
gum in preventing POI for adult patients who have undergone abdominal
surgeries.
2. To guide and assist nurses in providing care based on the best evidence in
preventing POI for adult patients who have undergone abdominal surgeries.
3. To ensure patients receiving consistent, standardized and evidence-based
care in the surgical units.
4.4 Target population of the proposed protocol
The target population includes all surgical patients who are aged 18 or
above, has undergone abdominal surgeries under general anesthesia for any
indication, with the ability to provide inform consent and to chew gum.
29
4.5 Rating scheme for the strength of the evidence and grades of the
recommendations
The Scottish Intercollegiate Guidelines Network (SIGN) is used to rate the
level of evidence with scoring from 1++ to 4 with 1++as the highest and 4 as the
lowest. It rates the grades of recommendations with grading with A, B, C, D
and whereas A is the highest grade and D is the lowest grade for
recommendation. indicates the best practice recommended. (Scottish
Intercollegiate Guidelines Network, 2014) (Appendix 7)
4.6 Recommendations
Assessment
Recommendation 1 Grade of recommendation: A
Assess patients’ ability to follow instruction and to chew gum.
Patients have to be aged 18 or above, whom has the ability to provide written
informed consent, to chew gum and to report for their first flatus.
Supporting evidence:
-It is important for the patients have full understanding to the intervention
ahead and agreement to undergo. It is also important to ensure patients dental
condition. Patients having loose teeth or dentures may not fit for the
intervention. Patients’ cooperation of reporting first flatus would help nurses to
know the process of the intervention. (Chol. 2011; Ertas, 2013; Marwah, 2012;
Schuster, 2006) (1+)
Recommendation 2 Grade of recommendation: A
Exclude the patients who are ineligible to receiving chewing gum.
Cases of emergency surgery, postoperative admission to ICU or requiring
30
postoperative intubation, subjects with previous bowel surgery, complaints of
chronic constipation, history of inflammatory bowel diseases, thyroid diseases,
intestinal obstruction, abdominal radiation or neoadjuvant chemotherapy are all
not fit to undergo the chewing gum protocol.
Supporting evidence:
-To exclude patients who are ineligible could prevent ineffective use of the new
innovation, which may fail to yield expected outcome in specific cases. It also
prevents the misuse of chewing gum in patients who are not fit to use. This could
minimize the adverse reaction causing from the chewing gum though it is in rare
cases. (Chol. 2011; Ertas, 2013; Marwah, 2012; Terzioglu, 2012) (1+)
Intervention
Recommendation 3 Grade of recommendation: A
Using sugarless gum for the chewing gum protocol.
Sugarless gum would be selected as the only choice of gum for the patients to
use.
Supporting evidence:
-Sugarless gum appears to be the best choice of gum comparing to those with
taste or flavor. It is because sugarless gum can prevent any harmful event to
patients who are restricted to sugar intake or having allergy to any kind of spices
or artificial flavoring. (Chol. 2011; Ertas, 2013; Schuster, 2006) (1+)
Recommendation 4 Grade of recommendation: A
Starts the chewing gum protocol on postoperative day 1.
The chewing gum protocol will start on postoperative day 1. For patients who
have difficulties to start the chewing gum protocol, they could postpone it until
they are physically and mentally fit for it; or exclude from it when they meet an
31
exclusive criteria.
Supporting evidence:
-Most patients recover to full consciousness within 6 hours after the operation.
Concerning of the possible fatigue from the operation, postoperative day 1
appears to be the best timing to start the chewing gum protocol, which allows
patients time to rest before getting start. The principle is to start the protocol as
soon as possible to make the prevention effective. (Ertas, 2013; Schuster, 2006)
(1+)
Recommendation 5 Grade of recommendation: A
Chewing gum regimen scheduled to 3 times per day, 30min per time.
The most favorable dosage of chewing gum would be 3 times per day. Having
30min for each section is appropriate after balancing the cost and benefit of
using it.
Supporting evidence:
-According to the studies related to chewing gum and the return of gut
movement, there is a significant result showing that the more gum patients
chew, the shortest time they have their first flatus and bowel sound heard after
surgeries. However, it is not a pleasant experience to chew gum all the day. It
may cause heavy burden to nurses if the dosage of chewing gum is too frequent.
Comparing different results from the studies, 3 times per day and 30min per
time appear to be the optimal dosage that is more acceptable for nurses and
patients, it also yields reasonable results. (Chol. 2011; Ertas, 2013) (1+)
Recommendation 6 Grade of recommendation: A
The chewing gum protocol (Appendix 11) will be continued until the return of
bowel function.
32
The chewing gum protocol starts on postoperative day 1 and would be ended at
the time after their first flatus and first bowel sound heard. For patients who are
not suitable to continue the protocol, such as having health deterioration, the
intervention will also be stopped.
Supporting evidence:
-The chewing gum protocols successfully prevent POI when knowing that the
bowel movement is return. Patient would be able to proceed to digest solid food
afterwards. (Chol. 2011; Ertas, 2013; Marwah, 2012) (1+)
Evaluation
Recommendation 7 Grade of recommendation: A
Nurses will check patients’ first bowel sound and will record the time of the first
flatus.
Patients will be asked to report when they pass their first flatus after surgeries.
Nurses will also check for patients’ bowel sound hourly using stereoscopes.
Nurses will record the time of the first flatus and bowel sound. They are the two
important criteria to prove the return of gut motility in the chewing gum
protocol.
Supporting evidence:
-Gut movement produces stool and gases. For patients who have undergone
fasting, the passage of flatus is an important sign of gut movement. By recording
the time of first flatus and bowel sound, it can be used for comparison with
control groups. (Chol. 2011; Ertas, 2013; Marwah, 2012; Schuster, 2006,
Terzioglu, 2012) (1+)
33
Chapter 5: Implementation plan
To implement the use of chewing gum in surgical adult patients into
clinical practice, it is important to integrate the concepts from the new evidenced
based innovation into the thinking and practice of the healthcare professionals
(Melnyk, & Fineout-Overholt, 2005). Disseminating and implementing of the
chewing gum protocol to stakeholders need a communication plan. It helps to
convince others in the local setting to implement a new innovation.
5.1 Stakeholders
Stakeholders are people who are affected by the proposed changes or
anticipated results of the proposed innovation (Melnyk, & Fineout-Overholt,
2005). Different categories of stakeholders share different characteristics, role
and responsibilities. They may have different concerns and needs in the
implementation of the new innovation.
In the chewing gum protocol for postoperative adult patients, the key
stakeholders are the Department Operational Manager (DOM), surgical ward
managers and the consultants of the department of surgery. They are the
administrators who have the highest administrative power to approve the chewing
gum protocol. They are also responsible in approving resources such as budgets and
manpower for the clinical adjustment and innovation implementation.
Frontline nurses including APN and RN in the surgical units are the largest
group of stakeholders. They are responsible to follow the new guidelines and to carry
34
out pilot study. They are responsible in assessment, planning and evaluation. For APN,
they have to be trained to be trainer. They are responsible in problem solving and to
act as a bridge of communication between RN and the administrators. The
introduction of new chewing gum protocol brings changes to current practice. A
certain amount of workload may be added to their duty.
Doctors are involving in selecting suitable patients for the chewing gum
protocol. They prescribe chewing gum to those suitable patients and involve in
monitoring of effects. They have the responsibly to terminate the intervention if
needed.
5.2 Planning
A working group with 7 to 8 people is initiated. The leader is the proposer
of the chewing gum protocol. For the members, they are the DOM, the manager,
the SMO, the APN and representatives from RN and medical officers. The
working group will hold regular meetings for discussing about how and when to
implement the chewing gum protocol. Issues on formulating guidelines and staff
training will also be discussed. Adjustment for the clinical area will be made after
discussion. Possible difficulties and barrier would be discussed in the
preparation plan so as to minimize obstacles of the new guidelines. A pilot study
plan will eventually scheduled.
After effective and sufficient meetings of the working group, the group
members will disseminate plans and information to all stakeholders. Nurses are
the first group of stakeholders to be convinced because they are responsible to
35
many major parts of the protocol. APN and nurse representatives will report the
progress from the meeting from time to time. Queries from stakeholders could
be raised out at anytime. The working group members will collect all comments
and queries back to the meetings for problem shooting. This facilitates
information exchange from all levels of stakeholders.
For clinical adjustment, the selected chewing gum will be supplied to
ward. A storage area will be assigned for the gum. An additional 50 stereoscopes
will also be applied to ward. Staff training will begin shortly; part time nurses
will be recruited to replace manpower during training.
5.3 Sustaining the change
Sustaining the change is one important part in translational nursing.
Nurses’ compliance to the new protocol will be audited by their documentation
and charting. Patients’ outcome will be monitored. Equipment and resources
availability have to be ensured for use. Regular ward meeting and working group
meetings will be carry on for discussing feedbacks and comments from
stakeholders. In the meetings, difficulties and problems from staff will be
encountered. Success stories will also be shared. Modification of the guidelines
will be made according to actual needs. New adjustment will be announced to
staff during handover time. The guideline will be reviewed from time to time so
as to make it updated.
36
Chapter 6: Pilot study test
A pilot study will be held to test the feasibility of the chewing gum
protocol. It is to test the logistics of the guideline before the large-scale
implementation. It allows the chewing gum protocol to be revised if needed.
Therefore, a pilot study test will be carried out in one surgical ward for eight
weeks before the large-scale implementation.
6.1 Objectives of the pilot study test
There are two objectives for the pilot study test. Firstly, it is to test the
feasibility of the chewing gum protocol. Secondly, it is to test the logistics of the
protocol and to assess the evaluation tools.
6.2 Study design and sample recruitment
The pilot study lasts for eight weeks. It will be held in one male surgical
ward of a government hospital. According to the previous admission record of
the ward, around 20 eligible patients will be recruited in the pilot study. Nurses
will recruit them on the day before their operation. The sample size of this pilot
study would therefore be 20. It takes around 3 weeks to recruit 20 patients. The
inclusion and exclusion criteria for samples in this pilot test will be the same as
the criteria in the proposed chewing gum guideline. Written consent will be
obtained from all eligible patients who agree to take part in this pilot study.
37
6.3 Data collection
Baseline assessment
After recruitment of patients, ward nurses will explain to eligible patients
the pilot study in detail. Nurses will have screening on patients’ planned
operation; assess their ability in chewing and reporting. Doctors will also access
patients’ bowel sound for baseline record. All eligible patients’ information will
be documented including their gender, age, chewing ability, bowel habit and
bowel sound.
Intervention
Chewing gum will be administered to patients according to the proposed
protocol after they have undergone abdominal operation. The proposed
administration time will be their postoperative Day 1 but it may varies
depending on the actual physical condition of the patients. Patients’ chewing
process will be observed and timed by nurses. They are asked to discard gum
after 30 min. They will also be asked to discard gum once they have encounter
difficulty in chewing so as to avoid accidentally swallow of gum. Nurses will
monitor patients’ bowel sound hourly. Patients are responsible to report their
first flatus to nurses once it occurs. They are also required to report symptoms of
paralytic ileus including abdominal pain and vomiting. Documentation will be
done to record patients’ compliance to chewing gum, their bowel sound and their
first flatus.
38
Apart from patient data, opinion from stakeholders from the chewing
gum protocol will also be collected for later evaluation. The actual cost spending
on the protocol will be recorded for budget evaluation.
6.4 Data analysis
Data on the incidence of paralytic ileus of patients in these eight weeks
will be analyzed and compared with the ward record. It is to test the
effectiveness and feasibility of the chewing gum protocol. Patients’ time of first
bowel sound and their first flatus will be used for comparison. For those who
quit the study, their reasons behind will be documented for later analysis. A
questionnaire will be distributed to patients for their evaluation of the protocol.
It is attached in appendix 8.
For the staff, their compliance and acceptance to the chewing gum
protocol will be investigated in the study. Questionnaires will be used to collect
staff feedback. The questionnaire is attached in appendix 9. Sharing sections on
chewing gum protocol will be conducted weekly at handover time. By observing
the logistic of the implementation of the protocol, the effectiveness of the
training process and resources support will be evaluated.
6.5 Evaluation of pilot study
39
Results of the pilot study include feasibility and effectiveness of the new
protocol. Through the pilot study, the logistic of the chewing gum intervention
can be tested in trial. Potential technical problems in implementing the protocol
can be identified. Prevention and solution to the problems can be made before
encountering them in the large- scale implementation. Budget plan will be more
concrete for revision. Besides, staff compliance and acceptance to the protocol
will be evaluated. Difficulties from staff will be identified. Their comments will be
considered in revision of the protocol. The experience from the pilot study will
be useful for modification of the protocol. Finalized protocol will finally be
reported to administer for approval.
40
Chapter 7: Evaluation plan
By evaluation, the proposed protocol could be determined whether it has
met the expected outcomes. It is also important in verifying its success or failure.
Several outcomes are identified for the evaluation. They are patient outcomes,
healthcare provider outcomes and system outcomes.
7.1 Identifying outcomes to be achieved
Patient outcomes
The primary outcome of the chewing gum protocol is to reduce paralytic
ileus in adult patients after abdominal surgeries. The return of bowel sound and
first flatus are considered to be measurement in determining the effectiveness of
the protocol. Nurses perform auscultation for patients’ bowel sound hourly.
Patients’ report on first flatus and ileus symptoms are used as another
measurement. The monitoring will start from postoperative day 1 until the
return of patient’s bowel movement.
Patient’s satisfaction level towards the chewing gum intervention is
considered as the secondary outcome. They will complete an evaluation
concerning the intervention before discharge.
Healthcare provider outcomes
Health care providers’ acceptance and satisfaction level towards the
protocol are considered as their outcomes. Their attitude towards training,
41
compliance, and competency all along the implementation process will be
evaluated. Another set of evaluation form will be distributed to the frontline
staff for evaluation. Besides, the working group of the chewing gum protocol will
audit the nursing documentation and charting to check for the compliance.
System outcomes
The cost effectiveness of the chewing gum protocol will be measured as
the system outcomes. All material and non-material cost will be calculated at the
end of implementation period. Patients’ outcome will also be considered
whether it is worth to continue the protocol. Possible adverse events will be
taken into consideration. Comparison will be made between usual practice and
the use of new protocol.
7.2 nature and number of patients involved
Nature of clients to be involved
The nature of clients in the evaluation plan is the same as the nature of
eligible clients in the chewing gum protocol. They have to be aged 18 or above
with any indication which have them undergone abdominal operation under
general anesthesia, without any exclusive criteria from the protocol, admitting to
the target surgical unit.
Number of clients to be involved
42
The number of clients to be involved in the evaluation plan is determined
by the incidence rate of abdominal surgeries; which may complicate with
paralytic ileus. From the reviewed studies investigating the effectiveness of the
use of chewing gum in preventing postoperative ileus, 34 to 152 patients were
recruited. Although they share variable sample size, all the selected studies have
proved statistically significant in using chewing gum. They all show that patients
who start chewing gum after surgery have an earlier return of bowel sound and
flatus. Therefore, 175 patients will be recruited in the evaluation plan to examine
the effectiveness of the new protocol. According to the admission record of the
target institution, it will take 7 months to recruit 175 patients.
7.3 Data collection and analysis
Based on the previous selected studies, patients’ return of gut motility
will be monitored from postoperative day one until their first flatus and first
bowel sound heard. Patients’ data will be collected and input to computer for
analysis. For satisfaction level, all evaluation questionnaires will be collected
after the implementation period. The defined level of significance for the analysis
is 0.05 and the confidence interval is 95%.
Patient outcomes
Nurse assesses the bowel movement of patients routinely. They make use
of stereoscope to auscultate patient’ lower abdomen hourly. The bowel sound
would either be heard or not heard. Therefore, it will be documented as bowel
43
sound positive (+) or negative (-). Moreover, nurses will also assess patients’
occurrence of flatus and ileus symptoms. They will all be documented as positive
(+) or negative (-) in the documentation with accurate time record.
For the satisfaction level of patients, they will fill in a questionnaire before
discharge. The questionnaire consists of 7 questions for rating whereas 1=
strongly disagree and 5= strongly agree (Appendix 8). The total score of the
questionnaire raged from 7 to35. The last question is open-ended; which allows
patients to reflect their own comments. Mean, SD and descriptive statistics will
be used to illustrate the data. All comments from the last question will be
collected and discuss in the meetings.
Healthcare provider outcomes
Questionnaire for healthcare provider will be distributed at the end of
implementation period of the protocol. It is a set of questionnaire with similar
format with the patient evaluation form. The total score of the questionnaire
raged from 7 to35. The last question is open-ended; which allows healthcare
provider to reflect their opinion to the protocol. Mean, SD and descriptive
statistics will be used to illustrate the data. All comments from the last question
will be collected considered as valuable resources for further modification of the
protocol.
System outcomes
Comparison on incidence rate of postoperative paralytic ileus and total
cost will be made between the chewing gum protocol and the original practice.
44
The protocol will be regarded as successful if the incidence rate decreased with
30% and the cost is cut down with 30% for maintaining current practice.
7.4 Effective criteria for the protocol
Time to first bowel movement
The time to first bowel movement was monitored in all of the five studies
(Ertas, 2013; Terzioglu, 2012; Schuster, 2006; Marwah, 2012; Chol, 2011).
Among all review studies, they record the time from the time patient return from
recovery room until their first bowel sound heard. The time record is measured in
terms of hour. Comparison between control group (CG) and intervention
group (IG) were made. All resulted in a shorter time in the intervention group for
the first bowel sound. The shorter mean time of IG from the five studies varies
from 3.92 (24.3%)hours to 26.2 (29.3%)hours. After analysis, the protocol will
be regarded as successful if the patients under the chewing gum protocol have
25% faster in time for first bowel sound compared with patients without
chewing gum treatment.
Time of postoperative first flatus
In the review studies, the time reported from patients under chewing gum
protocol for their first flatus is commonly faster than patients with normal
practice. The shorter mean time of IG from the five studies varies from 6.07
(18.8%) hours to 14.8 (18.5%)hours. After analysis, the protocol will be regarded
as successful if the patients under the chewing gum protocol have 18%
45
faster in time for first flatus compared with patients without chewing gum
treatment.
Satisfaction level of patients and healthcare provider
All numeric data will be collected and analyzed with SD and mean.
Comments from the last question of both set of questionnaire will be remarked
for discussion during meeting. It is expected that over 75% of patients and
healthcare providers are satisfactory to the chewing gum protocol.
46
Chapter 8: Conclusion
Conclusion
The chewing gum protocol is feasible and transferable. It is harmless with
low cost. It is a noninvasive, which is favorable for patients with postoperative
ileus (POI). Although there is still data showing not all patients receive effect
from it, it brings no complication. It is worth to apply the protocol so as to
reduce POI in patients.
Establishing the chewing gum protocol can help patients, health care staff
and also the medical system. There is not much extra skill and workload for staff.
There is not much expenditure for the medical system as well. However, it brings
much more comfort and recovery to patients. By fine-tuning the protocol from
time to time, it is believed that the chewing gum protocol will be considered as
an easy prevention for POI.
48
Appendix 1: Table of evidence Citation/
Study Design/
Country of study
Evidence level
Subject Characteristics
Intervention
Control
Outcomes
measures/Length of follow up
Effect size
Interpretation
Ertas (2013) Influence of gum chewing on postoperative bowel activity after complete staging surgery for gynecological malignancies: A randomized controlled trail, Gynecologic oncology 131 (2013) 118-122
• RCT • Turkey
1(+) • n=152 • Mean age=
52.05
Standard normal care
Began chewing gum on postop D1 and chew gum three times daily. Each chewing lasts 30min.
Standard normal care
1. Time to first bowel movement (h)
2. Postop first flatus time (h)
Length of FU
Period from the end of surgery until the time patient has bowel sound return.
1. The mean time to bowel movement in IG is 8.6 (h) faster than CG.
2. The mean time of first flatus in IG is 9.6 (h) faster than CG.
Gum chewing early in the postoperative period following elective total abdominal hysterectomy and systematic retroperitoneal lymphadenectomy hastens time to bowel motility.
Footnote: h=hours; IG=intervention group; CG=control group
49
Citation/ Study
Design/ Country of
study
Evidence level
Subject Characteristics
Intervention
Control
Outcomes
measures/Length of follow up
Effect size
Interpretation
Terzioglu (2012) Multimodal interventions (chewing gum, early oral hydration and early mobilization) on the intestinal motility following abdominal gynaecologic surgery, Journal of clinical Nursing, 22, 1917-1925
• RCT • Turkey
1(+) • n=60 • Aged 50 or
below= 73.3%; aged 51 or above= 26.7%
Standard normal care
Chewing sugarless gum for a period of 15minutes once every 2 hours after the operation, which was ceased between 00:00 and 08:00.
Standard normal care
1. Time of first bowel sound (h)
2. Time of first passage of flatus (h)
Length of FU
Period from the end of surgery until the time patient has bowel sound return.
1. The mean time of first bowel sound in IG is 3.92 (h) faster than CG.
2. The mean time of first flatus in IG is 6.07(h) faster than CG.
Chewing gum is an effective method in preventing paralytic ileus after gynaecological surgeries with significant improvement in patients’ comfort.
Footnote: h=hours; IG=intervention group; CG=control group
50
Citation/ Study
Design/ Country of
study
Evidence level
Subject Characteristics
Intervention
Control
Outcomes
measures/Length of follow up
Effect size
Interpretation
Schuster (2006), Gum chewing reduces ileus after elective open sigmoid colectomy, American Medical Association, ARCG SURG/VOL 141, Feb 2006
• RCT • California
1(+) • n=34 • Mean age=
61.5
Standard normal care
Gum chewing began in the morning of postoperative day 1, patients chew sugarless gum 3 times daily in the morning, afternoon and evening.
Standard normal care
1. Time of first bowel movement (h)
2. Time of first passage of flatus (h)
Length of FU
Period from the end of surgery until the time patient has bowel function return.
1. The mean time of first bowel movement in IG is 26.2 (h) faster than CG.
2. The mean time of first flatus in IG is 14.8(h) faster than CG.
Gum chewing speeds up recovery after elective open sigmoid resection by stimulating bowel motility.
Footnote: h=hours; IG=intervention group; CG=control group
51
Citation/ Study
Design/ Country of
study
Evidence level
Subject Characteristics
Intervention
Control
Outcomes
measures/Length of follow up
Effect size
Interpretation
Marwah (2012), Role of gum chewing on the duration of postoperative ileus following ileostomy closure done for typhoid ileal perforation: A prospective randomized trial, The Saudi Journal of gastroenterology, Volume 18, no.2, Rabi Ai Thany 1433
• RCT • India
1(+) • n=100 • Mean age=
38.42
Standard normal care
To chew sugar-free gum 3 times per day for 1 hour each time, starting from 6 hours after the surgery until the passage of first flatus.
Standard normal care
1. Time of first bowel sound (h)
2. Time of first passage of flatus (h)
Length of FU
Period from the end of surgery until the time patient has bowel sound return.
1. The mean time of first bowel sound in IG is 7.92(h) faster than CG.
2. The mean time of first flatus in IG is 14.64(h) faster than CG.
Gum chewing shows significance in reducing the duration of POI after laparotomy for ileostomy closure, which was done for typhoid perforation peritonitis.
Footnote: h=hours; IG=intervention group; CG=control group
52
Citation/ Study
Design/ Country of
study
Evidence level
Subject Characteristics
Intervention
Control
Outcomes
measures/Length of follow up
Effect size
Interpretation
Chol (2011) Chewing gum has a stimulatory effect on bowel motility in patients after open or robotic radical cystectomy for bladder cancer: A prospective randomized comparative study, Urology. 2011 Apr;77(4):884-90. doi: 10.1016
• RCT • Korea
1(+) • n=64 • Mean age= 64
Standard normal care
To chew sugar-free gum 3 times per day for 30min each time until the passage of first flatus.
Standard normal care
1. Time of first bowel sound (h)
2. Time of first passage of flatus (h)
Length of FU
Period from the end of surgery until the time patient has bowel sound return.
1. The mean time of first bowel sound in IG is 16.6 (h) faster than CG.
2. The mean time of first flatus in IG is 12.4 (h) faster than CG.
Chewing gum has stimulatory effects on bowel motility after cystectomy and urinary diversion. It is safe and could be used for postoperative ileus.
Footnote: h=hours; IG=intervention group; CG=control group
Appendix 2 SIGN Checklist
2.1 Ertas (2013), Gynecologic oncology 131 (2013) 118-122 2.2 Terzioglu (2012), Journal of clinical Nursing, 22, 1917-1925 2.3 Schuster (2006), American Medical Association, ARCG SURG/VOL 141, Feb 2006 2.4 Marwah (2012), Volume 18, no.2, Rabi Ai Thany 1433 2.5 Hoon Chol, (2011) Urology 2011 Apr;77(4):884-90. doi: 10.1016
53
S I G N
Methodology Checklist 2: Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages) Ertas (2013), Gynecologic oncology 131 (2013) 118-122
Guideline topic: Influence of gum chewing on postoperative bowel activity after complete staging surgery for gynecological malignancies: A randomized controlled trail
Key Question No: Reviewer:
Before completing this checklist, consider:
1. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+
2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention
Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.
Reason for rejection: 1. Paper not relevant to key question 2. Other reason (please specify):
SECTION 1: INTERNAL VALIDITY
In a well conducted RCT study…
Does this study do it?
1.1 The study addresses an appropriate and clearly focused question.i Yes No
Can’t say
1.2 The assignment of subjects to treatment groups is randomised.ii Yes No Can’t say
1.3 An adequate concealment method is used.iii Yes No Can’t say
1.4 Subjects and investigators are kept ‘blind’ about treatment allocation.iv
Yes No Can’t say
1.5 The treatment and control groups are similar at the start of the trial.v
Yes No Can’t say □
1.6 The only difference between groups is the treatment under investigation.vi
Yes No Can’t say
1.7 All relevant outcomes are measured in a standard, valid and reliable way.vii
Yes No Can’t say
1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?viii
1.97%
1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis).ix
Yes No Can’t say Does not
apply
1.10 Where the study is carried out at more than one site, results are comparable for all sites.x
Yes Can’t say
No Does not apply
54
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SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1
How well was the study done to minimise bias? Code as follows:xi
High quality (++) Acceptable (+)
Unacceptable – reject 0
2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?
Can’t say
2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?
Yes
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above.
There is significant different difference between IG and CG. The patients are not blind but it is blind to the assessors. It may be possible to make it blind to patients in this study as well.
i Unless a clear and well defined question is specified, it will be difficult to assess how well the study has met its objectives or how relevant it is to the question you are trying to answer on the basis of its conclusions.
ii Random allocation of patients to receive one or other of the treatments under investigation, or to receive either treatment or placebo, is fundamental to this type of study.
iii Allocation concealment refers to the process used to ensure that researchers are unaware which group patients are being allocated to at the time they enter the study. Research has shown that where allocation concealment is inadequate, investigators can overestimate the effect of interventions by up to 40%.
iv Blinding refers to the process whereby people are kept unaware of which treatment an individual patient has been receiving when they are assessing the outcome for that patient. It can be carried out up to three levels. Single blinding is where patients are unaware of which treatment they are receiving. In double blind studies neither the clinician nor the patient knows which treatment is being given. In very rare cases studies may be triple blinded, where neither patients, clinicians, nor those conducting the analysis are aware of which patients received which treatment. The higher the level of blinding, the lower the risk of bias in the study.
v Patients selected for inclusion in a trial must be as similar as possible. The study should report any significant differences in the composition of the study groups in relation to gender mix, age, stage of disease (if appropriate), social background, ethnic origin, or co-morbid conditions. These factors may be covered by inclusion and exclusion criteria, rather than being reported directly. Failure to address this question, or the use of inappropriate groups, should lead to the study being downgraded.
vi If some patients received additional treatment, even if of a minor nature or consisting of advice and counselling rather than a physical intervention, this treatment is a potential confounding factor that may invalidate the results. If groups were not treated equally, the study should be rejected unless no other evidence is available. If the study is used as evidence it should be treated with caution.
vii The primary outcome measures used should be clearly stated in the study. If the outcome measures are not stated, or the study bases its main conclusions on secondary outcomes, the study should be rejected. Where outcome measures require any degree of subjectivity, some evidence should be provided that the measures used are reliable and have been validated prior to their use in the study.
viii The number of patients that drop out of a study should give concern if the number is very high. Conventionally, a 20% drop out rate is regarded as acceptable, but this may vary. Some regard should be paid to why patients dropped out, as
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well as how many. It should be noted that the drop out rate may be expected to be higher in studies conducted over a long period of time. A higher drop out rate will normally lead to downgrading, rather than rejection of a study.
ix In practice, it is rarely the case that all patients allocated to the intervention group receive the intervention throughout the trial, or that all those in the comparison group do not. Patients may refuse treatment, or contra-indications arise that lead them to be switched to the other group. If the comparability of groups through randomisation is to be maintained, however, patient outcomes must be analysed according to the group to which they were originally allocated irrespective of the treatment they actually received. (This is known as intention to treat analysis.) If it is clear that analysis was not on an intention to treat basis, the study may be rejected. If there is little other evidence available, the study may be included but should be evaluated as if it were a non-randomised cohort study.
x In multi-site studies, confidence in the results should be increased if it can be shown that similar results were obtained at the different participating centres.
xi Rate the overall methodological quality of the study, using the following as a guide: High quality (++): Majority of criteria met. Little or no risk of bias. Results unlikely to be changed by further research. Acceptable (+): Most criteria met. Some flaws in the study with an associated risk of bias, Conclusions may change in the light of further studies. Low quality (0): Either most criteria not met, or significant flaws relating to key aspects of study design. Conclusions likely to change in the light of further studies.
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S I G N
Methodology Checklist 2: Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages) Terzioglu (2012), Journal of clinical Nursing, 22, 1917-1925
Guideline topic: Multimodal interventions (chewing gum, early oral hydration and early mobilization) on the intestinal motility following abdominal gynaecologic surgery
Key Question No: Reviewer:
Before completing this checklist, consider:
1. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+
2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention
Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.
Reason for rejection: 1. Paper not relevant to key question 2. Other reason (please specify):
SECTION 1: INTERNAL VALIDITY
In a well conducted RCT study…
Does this study do it?
1.1 The study addresses an appropriate and clearly focused question.i Yes No
Can’t say
1.2 The assignment of subjects to treatment groups is randomised.ii Yes No
Can’t say
1.3 An adequate concealment method is used.iii Yes No Can’t say
1.4 Subjects and investigators are kept ‘blind’ about treatment allocation.iv
Yes No Can’t say
1.5 The treatment and control groups are similar at the start of the trial.v
Yes No Can’t say
1.6 The only difference between groups is the treatment under investigation.vi
Yes No Can’t say
1.7 All relevant outcomes are measured in a standard, valid and reliable way.vii
Yes No Can’t say
1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?viii
Did not mention
1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis).ix
Yes No Can’t say Does not
apply
1.10 Where the study is carried out at more than one site, results are comparable for all sites.x
Yes Can’t say
No Does not apply
57
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SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1
How well was the study done to minimise bias? Code as follows:xi
High quality (++) Acceptable (+)
Unacceptable – reject 0
2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?
Can’t say
2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?
Yes
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above.
Chewing gum may have its optimal effectiveness in preventing POI when using together with other intervention such as early oral hydration and early mobilization. Drop out rate from this study should be mentioned.
i Unless a clear and well defined question is specified, it will be difficult to assess how well the study has met its objectives or how relevant it is to the question you are trying to answer on the basis of its conclusions.
ii Random allocation of patients to receive one or other of the treatments under investigation, or to receive either treatment or placebo, is fundamental to this type of study.
iii Allocation concealment refers to the process used to ensure that researchers are unaware which group patients are being allocated to at the time they enter the study. Research has shown that where allocation concealment is inadequate, investigators can overestimate the effect of interventions by up to 40%.
iv Blinding refers to the process whereby people are kept unaware of which treatment an individual patient has been receiving when they are assessing the outcome for that patient. It can be carried out up to three levels. Single blinding is where patients are unaware of which treatment they are receiving. In double blind studies neither the clinician nor the patient knows which treatment is being given. In very rare cases studies may be triple blinded, where neither patients, clinicians, nor those conducting the analysis are aware of which patients received which treatment. The higher the level of blinding, the lower the risk of bias in the study.
v Patients selected for inclusion in a trial must be as similar as possible. The study should report any significant differences in the composition of the study groups in relation to gender mix, age, stage of disease (if appropriate), social background, ethnic origin, or co-morbid conditions. These factors may be covered by inclusion and exclusion criteria, rather than being reported directly. Failure to address this question, or the use of inappropriate groups, should lead to the study being downgraded.
vi If some patients received additional treatment, even if of a minor nature or consisting of advice and counselling rather than a physical intervention, this treatment is a potential confounding factor that may invalidate the results. If groups were not treated equally, the study should be rejected unless no other evidence is available. If the study is used as evidence it should be treated with caution.
vii The primary outcome measures used should be clearly stated in the study. If the outcome measures are not stated, or the study bases its main conclusions on secondary outcomes, the study should be rejected. Where outcome measures require any degree of subjectivity, some evidence should be provided that the measures used are reliable and have been validated prior to their use in the study.
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viii The number of patients that drop out of a study should give concern if the number is very high. Conventionally, a 20% drop out rate is regarded as acceptable, but this may vary. Some regard should be paid to why patients dropped out, as well as how many. It should be noted that the drop out rate may be expected to be higher in studies conducted over a long period of time. A higher drop out rate will normally lead to downgrading, rather than rejection of a study.
ix In practice, it is rarely the case that all patients allocated to the intervention group receive the intervention throughout the trial, or that all those in the comparison group do not. Patients may refuse treatment, or contra-indications arise that lead them to be switched to the other group. If the comparability of groups through randomisation is to be maintained, however, patient outcomes must be analysed according to the group to which they were originally allocated irrespective of the treatment they actually received. (This is known as intention to treat analysis.) If it is clear that analysis was not on an intention to treat basis, the study may be rejected. If there is little other evidence available, the study may be included but should be evaluated as if it were a non-randomised cohort study.
x In multi-site studies, confidence in the results should be increased if it can be shown that similar results were obtained at the different participating centres.
xi Rate the overall methodological quality of the study, using the following as a guide: High quality (++): Majority of criteria met. Little or no risk of bias. Results unlikely to be changed by further research. Acceptable (+): Most criteria met. Some flaws in the study with an associated risk of bias, Conclusions may change in the light of further studies. Low quality (0): Either most criteria not met, or significant flaws relating to key aspects of study design. Conclusions likely to change in the light of further studies.
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S I G N
Methodology Checklist 2: Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages) Schuster (2006), American Medical Association, ARCG SURG/VOL 141, Feb 2006
Guideline topic: Gum chewing reduces ileus after elective open sigmoid colectomy
Key Question No: Reviewer:
Before completing this checklist, consider:
1. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+
2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention
Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.
Reason for rejection: 1. Paper not relevant to key question 2. Other reason (please specify):
SECTION 1: INTERNAL VALIDITY
In a well conducted RCT study…
Does this study do it?
1.1 The study addresses an appropriate and clearly focused question.i Yes No
Can’t say
1.2 The assignment of subjects to treatment groups is randomised.ii Yes No
Can’t say
1.3 An adequate concealment method is used.iii Yes No Can’t say
1.4 Subjects and investigators are kept ‘blind’ about treatment allocation.iv
Yes No Can’t say
1.5 The treatment and control groups are similar at the start of the trial.v
Yes No Can’t say □
1.6 The only difference between groups is the treatment under investigation.vi
Yes No Can’t say
1.7 All relevant outcomes are measured in a standard, valid and reliable way.vii
Yes No Can’t say
1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?viii
0%
1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis).ix
Yes No Can’t say Does not
apply
1.10 Where the study is carried out at more than one site, results are comparable for all sites.x
Yes Can’t say
No Does not apply
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SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1
How well was the study done to minimise bias? Code as follows:xi
High quality (++) Acceptable (+)
Unacceptable – reject 0
2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?
Can’t say
2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?
Yes
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above.
The sample size of this study is small. It explains a bit about the mechanism of sham feeding in the discussion part and it is appreciated.
i Unless a clear and well defined question is specified, it will be difficult to assess how well the study has met its objectives or how relevant it is to the question you are trying to answer on the basis of its conclusions.
ii Random allocation of patients to receive one or other of the treatments under investigation, or to receive either treatment or placebo, is fundamental to this type of study.
iii Allocation concealment refers to the process used to ensure that researchers are unaware which group patients are being allocated to at the time they enter the study. Research has shown that where allocation concealment is inadequate, investigators can overestimate the effect of interventions by up to 40%.
iv Blinding refers to the process whereby people are kept unaware of which treatment an individual patient has been receiving when they are assessing the outcome for that patient. It can be carried out up to three levels. Single blinding is where patients are unaware of which treatment they are receiving. In double blind studies neither the clinician nor the patient knows which treatment is being given. In very rare cases studies may be triple blinded, where neither patients, clinicians, nor those conducting the analysis are aware of which patients received which treatment. The higher the level of blinding, the lower the risk of bias in the study.
v Patients selected for inclusion in a trial must be as similar as possible. The study should report any significant differences in the composition of the study groups in relation to gender mix, age, stage of disease (if appropriate), social background, ethnic origin, or co-morbid conditions. These factors may be covered by inclusion and exclusion criteria, rather than being reported directly. Failure to address this question, or the use of inappropriate groups, should lead to the study being downgraded.
vi If some patients received additional treatment, even if of a minor nature or consisting of advice and counselling rather than a physical intervention, this treatment is a potential confounding factor that may invalidate the results. If groups were not treated equally, the study should be rejected unless no other evidence is available. If the study is used as evidence it should be treated with caution.
vii The primary outcome measures used should be clearly stated in the study. If the outcome measures are not stated, or the study bases its main conclusions on secondary outcomes, the study should be rejected. Where outcome measures require any degree of subjectivity, some evidence should be provided that the measures used are reliable and have been validated prior to their use in the study.
viii The number of patients that drop out of a study should give concern if the number is very high. Conventionally, a 20% drop out rate is regarded as acceptable, but this may vary. Some regard should be paid to why patients dropped out, as
61 File name : Checklist 2 – Controlled Trials Version 2.0 28/05/2012 Produced by: Carolyn Sleith Page of 3 Review date: None
well as how many. It should be noted that the drop out rate may be expected to be higher in studies conducted over a long period of time. A higher drop out rate will normally lead to downgrading, rather than rejection of a study.
ix In practice, it is rarely the case that all patients allocated to the intervention group receive the intervention throughout the trial, or that all those in the comparison group do not. Patients may refuse treatment, or contra-indications arise that lead them to be switched to the other group. If the comparability of groups through randomisation is to be maintained, however, patient outcomes must be analysed according to the group to which they were originally allocated irrespective of the treatment they actually received. (This is known as intention to treat analysis.) If it is clear that analysis was not on an intention to treat basis, the study may be rejected. If there is little other evidence available, the study may be included but should be evaluated as if it were a non-randomised cohort study.
x In multi-site studies, confidence in the results should be increased if it can be shown that similar results were obtained at the different participating centres.
xi Rate the overall methodological quality of the study, using the following as a guide: High quality (++): Majority of criteria met. Little or no risk of bias. Results unlikely to be changed by further research. Acceptable (+): Most criteria met. Some flaws in the study with an associated risk of bias, Conclusions may change in the light of further studies. Low quality (0): Either most criteria not met, or significant flaws relating to key aspects of study design. Conclusions likely to change in the light of further studies.
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S I G N
Methodology Checklist 2: Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages) Marwah (2012), Volume 18, no.2, Rabi Ai Thany 1433
Guideline topic: Role of gum chewing on the duration of postoperative ileus following ileostomy closure done for typhoid ileal perforation: A prospective randomized trial, The Saudi Journal of gastroenterology
Key Question No: Reviewer:
Before completing this checklist, consider:
1. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+
2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention
Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.
Reason for rejection: 1. Paper not relevant to key question 2. Other reason (please specify):
SECTION 1: INTERNAL VALIDITY
In a well conducted RCT study…
Does this study do it?
1.1 The study addresses an appropriate and clearly focused question.i Yes No
Can’t say
1.2 The assignment of subjects to treatment groups is randomised.ii Yes No
Can’t say
1.3 An adequate concealment method is used.iii Yes No Can’t say
1.4 Subjects and investigators are kept ‘blind’ about treatment allocation.iv
Yes No Can’t say
1.5 The treatment and control groups are similar at the start of the trial.v
Yes No Can’t say □
1.6 The only difference between groups is the treatment under investigation.vi
Yes No Can’t say
1.7 All relevant outcomes are measured in a standard, valid and reliable way.vii
Yes No Can’t say
1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?viii
0%
1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis).ix
Yes No Can’t say Does not
apply
1.10 Where the study is carried out at more than one site, results are comparable for all sites.x
Yes Can’t say
No Does not apply
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SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1
How well was the study done to minimise bias? Code as follows:xi
High quality (++) Acceptable (+)
Unacceptable – reject 0
2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?
Yes
2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?
Yes
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above.
The blinding is uncertain in this study.
i Unless a clear and well defined question is specified, it will be difficult to assess how well the study has met its objectives or how relevant it is to the question you are trying to answer on the basis of its conclusions.
ii Random allocation of patients to receive one or other of the treatments under investigation, or to receive either treatment or placebo, is fundamental to this type of study.
iii Allocation concealment refers to the process used to ensure that researchers are unaware which group patients are being allocated to at the time they enter the study. Research has shown that where allocation concealment is inadequate, investigators can overestimate the effect of interventions by up to 40%.
iv Blinding refers to the process whereby people are kept unaware of which treatment an individual patient has been receiving when they are assessing the outcome for that patient. It can be carried out up to three levels. Single blinding is where patients are unaware of which treatment they are receiving. In double blind studies neither the clinician nor the patient knows which treatment is being given. In very rare cases studies may be triple blinded, where neither patients, clinicians, nor those conducting the analysis are aware of which patients received which treatment. The higher the level of blinding, the lower the risk of bias in the study.
v Patients selected for inclusion in a trial must be as similar as possible. The study should report any significant differences in the composition of the study groups in relation to gender mix, age, stage of disease (if appropriate), social background, ethnic origin, or co-morbid conditions. These factors may be covered by inclusion and exclusion criteria, rather than being reported directly. Failure to address this question, or the use of inappropriate groups, should lead to the study being downgraded.
vi If some patients received additional treatment, even if of a minor nature or consisting of advice and counselling rather than a physical intervention, this treatment is a potential confounding factor that may invalidate the results. If groups were not treated equally, the study should be rejected unless no other evidence is available. If the study is used as evidence it should be treated with caution.
vii The primary outcome measures used should be clearly stated in the study. If the outcome measures are not stated, or the study bases its main conclusions on secondary outcomes, the study should be rejected. Where outcome measures require any degree of subjectivity, some evidence should be provided that the measures used are reliable and have been validated prior to their use in the study.
viii The number of patients that drop out of a study should give concern if the number is very high. Conventionally, a 20% drop out rate is regarded as acceptable, but this may vary. Some regard should be paid to why patients dropped out, as
64 File name : Checklist 2 – Controlled Trials Version 2.0 28/05/2012 Produced by: Carolyn Sleith Page of 3 Review date: None
well as how many. It should be noted that the drop out rate may be expected to be higher in studies conducted over a long period of time. A higher drop out rate will normally lead to downgrading, rather than rejection of a study.
ix In practice, it is rarely the case that all patients allocated to the intervention group receive the intervention throughout the trial, or that all those in the comparison group do not. Patients may refuse treatment, or contra-indications arise that lead them to be switched to the other group. If the comparability of groups through randomisation is to be maintained, however, patient outcomes must be analysed according to the group to which they were originally allocated irrespective of the treatment they actually received. (This is known as intention to treat analysis.) If it is clear that analysis was not on an intention to treat basis, the study may be rejected. If there is little other evidence available, the study may be included but should be evaluated as if it were a non-randomised cohort study.
x In multi-site studies, confidence in the results should be increased if it can be shown that similar results were obtained at the different participating centres.
xi Rate the overall methodological quality of the study, using the following as a guide: High quality (++): Majority of criteria met. Little or no risk of bias. Results unlikely to be changed by further research. Acceptable (+): Most criteria met. Some flaws in the study with an associated risk of bias, Conclusions may change in the light of further studies. Low quality (0): Either most criteria not met, or significant flaws relating to key aspects of study design. Conclusions likely to change in the light of further studies.
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S I G N
Methodology Checklist 2: Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages) Hoon Chol, (2011) Urology 2011 Apr;77(4):884-90. doi: 10.1016
Guideline topic: Chewing gum has a stimulatory effect on bowel motility in patients after open or robotic radical cystectomy for bladder cancer: A prospective randomized comparative study
Key Question No: Reviewer:
Before completing this checklist, consider:
1. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+
2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention
Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.
Reason for rejection: 1. Paper not relevant to key question 2. Other reason (please specify):
SECTION 1: INTERNAL VALIDITY
In a well conducted RCT study…
Does this study do it?
1.1 The study addresses an appropriate and clearly focused question.i Yes No
Can’t say
1.2 The assignment of subjects to treatment groups is randomised.ii Yes No
Can’t say
1.3 An adequate concealment method is used.iii Yes No Can’t say
1.4 Subjects and investigators are kept ‘blind’ about treatment allocation.iv
Yes No Can’t say
1.5 The treatment and control groups are similar at the start of the trial.v
Yes No Can’t say □
1.6 The only difference between groups is the treatment under investigation.vi
Yes No Can’t say
1.7 All relevant outcomes are measured in a standard, valid and reliable way.vii
Yes No Can’t say
1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?viii
6.25%
1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis).ix
Yes No Can’t say Does not
apply
1.10 Where the study is carried out at more than one site, results are comparable for all sites.x
Yes Can’t say
No Does not apply
66
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SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1
How well was the study done to minimise bias? Code as follows:xi
High quality (++) Acceptable (+)
Unacceptable – reject 0
2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?
Yes
2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?
Yes
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above.
Blinding is used in subjects but isn’t mentioned to investigators.
i Unless a clear and well defined question is specified, it will be difficult to assess how well the study has met its objectives or how relevant it is to the question you are trying to answer on the basis of its conclusions.
ii Random allocation of patients to receive one or other of the treatments under investigation, or to receive either treatment or placebo, is fundamental to this type of study.
iii Allocation concealment refers to the process used to ensure that researchers are unaware which group patients are being allocated to at the time they enter the study. Research has shown that where allocation concealment is inadequate, investigators can overestimate the effect of interventions by up to 40%.
iv Blinding refers to the process whereby people are kept unaware of which treatment an individual patient has been receiving when they are assessing the outcome for that patient. It can be carried out up to three levels. Single blinding is where patients are unaware of which treatment they are receiving. In double blind studies neither the clinician nor the patient knows which treatment is being given. In very rare cases studies may be triple blinded, where neither patients, clinicians, nor those conducting the analysis are aware of which patients received which treatment. The higher the level of blinding, the lower the risk of bias in the study.
v Patients selected for inclusion in a trial must be as similar as possible. The study should report any significant differences in the composition of the study groups in relation to gender mix, age, stage of disease (if appropriate), social background, ethnic origin, or co-morbid conditions. These factors may be covered by inclusion and exclusion criteria, rather than being reported directly. Failure to address this question, or the use of inappropriate groups, should lead to the study being downgraded.
vi If some patients received additional treatment, even if of a minor nature or consisting of advice and counselling rather than a physical intervention, this treatment is a potential confounding factor that may invalidate the results. If groups were not treated equally, the study should be rejected unless no other evidence is available. If the study is used as evidence it should be treated with caution.
vii The primary outcome measures used should be clearly stated in the study. If the outcome measures are not stated, or the study bases its main conclusions on secondary outcomes, the study should be rejected. Where outcome measures require any degree of subjectivity, some evidence should be provided that the measures used are reliable and have been validated prior to their use in the study.
viii The number of patients that drop out of a study should give concern if the number is very high. Conventionally, a 20% drop out rate is regarded as acceptable, but this may vary. Some regard should be paid to why patients dropped out, as
67 File name : Checklist 2 – Controlled Trials Version 2.0 28/05/2012 Produced by: Carolyn Sleith Page of 3 Review date: None
well as how many. It should be noted that the drop out rate may be expected to be higher in studies conducted over a long period of time. A higher drop out rate will normally lead to downgrading, rather than rejection of a study.
ix In practice, it is rarely the case that all patients allocated to the intervention group receive the intervention throughout the trial, or that all those in the comparison group do not. Patients may refuse treatment, or contra-indications arise that lead them to be switched to the other group. If the comparability of groups through randomisation is to be maintained, however, patient outcomes must be analysed according to the group to which they were originally allocated irrespective of the treatment they actually received. (This is known as intention to treat analysis.) If it is clear that analysis was not on an intention to treat basis, the study may be rejected. If there is little other evidence available, the study may be included but should be evaluated as if it were a non-randomised cohort study.
x In multi-site studies, confidence in the results should be increased if it can be shown that similar results were obtained at the different participating centres.
xi Rate the overall methodological quality of the study, using the following as a guide: High quality (++): Majority of criteria met. Little or no risk of bias. Results unlikely to be changed by further research. Acceptable (+): Most criteria met. Some flaws in the study with an associated risk of bias, Conclusions may change in the light of further studies. Low quality (0): Either most criteria not met, or significant flaws relating to key aspects of study design. Conclusions likely to change in the light of further studies.
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69
Appendix 3 Search history (Last search in May 2014)
PubMed (# Of citation)
CINAHL (# Of citation)
Mosby’s Nursing consult (# Of citation)
After keyword search (chewing gum + postoperative ileus)
61
23
11
After keyword search (sham feeding + postoperative ileus)
9
25
4
After keyword search (chewing gum + bowel movement)
37
107
19
After keyword search (chewing gum + postoperative care)
38
130
9
Total # of citations from keywords
145
285
43
Total # of citations from all databases: 473
After further screening of titles and abstracts
11
19
12
After reading full text
2
1
3
71
Incl
uded
El
igib
ility
Sc
reen
ing
Iden
tific
atio
n
Appendix 4 PRISMA flow for searching summary from 3 databases (PubMed, CINAHL, Mosby’s Nursing consult)
PRISMA 2009 Flow Diagram
Records identified through database searching
(n = 503)
Additional records identified through other sources
(n =2)
Records after duplicates removed (n = 473)
Records screened (n = 42)
Records excluded (n =431) Reasons: Non-primary studies (n=290) Non-journal publication (n=87) More than 10 years (n=54)
Full-text articles assessed for eligibility
(n = 6)
Records excluded (n=36) Reasons: Exclude by title (n=23) Exclude by abstract (n=13) Full-text articles excluded (n=1) Reasons: Methodological flaws (n=1)
Studies included in quantitative synthesis
(meta-analysis) (n = 5)
72
Appendix 5
Time schedule for implementing the innovation
It is estimated that the new innovation will take 58 weeks for implementation and evaluation.
Items
Schedule
Formation of a program committee for the new innovation- the chewing gum
protocol
4 weeks
Planning for the innovation including communication plan
6 weeks
Staff briefing and training
6weeks
Trial running for the program
8 weeks
Implementation period
28 weeks
Evaluation of the programs
6 weeks
73
Appendix 6 Estimated set up cost and operational cost
Estimated set up cost for implementation for 58 weeks Items Calculation Amount
Sugarless gum HKD$ 0.1 x 225 x 15 x 3 HKD$ 1012.5
Stereoscopes HKD$ 25 x 30 (set) HKD$ 750
Staff training HKD$ 300 (hr) x 50 (staff) HKD$ 15,000
Extra staff (registered nurse)
HKD$ 30000 x 1 (staff) x 12.5 (salary of 50 weeks)
HKD$ 375,000
Information pamphlet HKD$ 0.1 x 225 (page) HKD$ 22.5
Total set up cost HKD$ 391,785
Estimated operational cost per month/4 weeks Items Calculation Amount
Sugarless gum HKD$ 0.1 (piece) x 25(patients) x 15 x 3 (basic consumption of gum)
HKD$ 112.5
Staff tutorial class HKD$300 (hr) x 3 (staff) HKD$ 900
Extra staff (registered nurses)
HKD$ 30000 x 1 (staff) HKD$ 30,000
Information pamphlet HKD$0.1 x 25 (page) HKD$ 2.5
Total operational cost per month
HKD$ 31,015
Remarks:
1. Sugarless gum costs $0.1 per piece. 2. Estimate 25 patients undergo chewing gum protocol monthly (6.25
patients weekly). 3. 255 patients for 36 weeks of implementation including pilot study test. 4. 15 days is estimated as the maximum time for the treatment per patient
as most patients will not need to exist 15 days of treatment. 5. Each patient consumes 3 gums daily. 6. Expense on extra staff may have minor variation depending on the
individual point of salary.
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Appendix 7 Key to evidence statements and grades of recommendations by SCOTTISH INTERCOLLEGIATE GUIDELINES NETWORK
LEVEL OF EVIDENCE 1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias 1+ Well-conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias 1- Meta-analyses, systematic reviews, or RCTs with a high risk of bias 2++ High quality systematic reviews of case control or cohort or studies H igh
quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal 2+ Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal 2- Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal 3 Non-analytic studies, e.g. case reports, case series 4 Expert opinions
GRADES OF RECOMMENDATIONS A- At least one meta-analysis, systematic review, or RCT rated as 1++, and directly applicable to the target population; or A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results B- A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 1++ or 1+ C- A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 2++ D- Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2+
Good practice points Recommended best practice based on the clinical experience of the guideline development group
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Appendix 8
Patient evaluation form
Please “tick” the following:
1= Strongly disagree 2= Disagree 3= Neutral 4= Agree 5= Strongly agree
1
2
3
4
5
1. The chewing gum is useful in resuming bowel motility.
2. The chewing gum intervention is easy to follow.
3. The new treatment does not induce much discomfort
4. Nurses are always helpful and available for enquiry.
5. Nurses are competent in handling the new treatment protocol.
6. You are willing to use the new treatment protocol.
7. You are satisfied with the new treatment protocol.
8. Other comments:
76
Appendix 9
Health care providers’ evaluation form
Please “tick” the following:
1= Strongly disagree 2= Disagree 3= Neutral 4= Agree 5= Strongly agree
1
2
3
4
5
9. There is sufficient resources and support for implementing the protocol.
10. Sufficient training and instruction is provided for implementing the protocol.
11. The protocol do not add unacceptable burden to the original practice.
12. Patients are beneficial from the protocol
13. The new protocol can bring job satisfaction to you.
14. You feel confident in conducting the protocol
15. The protocol is worth implementing in a long run.
16. Other comments:
77
Appendix 10 Flow chart of decision making in the chewing gum protocol
Paitents undergone abdominal surgery and returned from recovery room
Postoperative day 1
Conscious Unconscious
Recruit to the protocol reject from the protocol
Can chew cannot chew reject
Start the chewing protocol
Follow protocol cannot follow protocol (e.g. fatigue) reject
Being cooperative in monitoring and reporting of flatus and discomfort
Yield useful data for the chewing gum protocol/ Patients beneficial from the protocol
78
Appendix 11 Guideline of gum chewing in preventing postoperative paralytic ileus in adult patients after abdominal surgeries
1. Objectives 1.1 To provide care for promoting optimal recovery from surgery 1.2 To minimize risk of postoperative paralytic ileus
2. Scope 2.1 The procedure covers all adult patients who aged 18 or above who have undergone abdominal surgery under general anesthesia.
3. Nursing intervention 3.1 Post-operative care day 1 3.1.1 check patient’s conscious level 3.1.2 check patient’s ability in chewing and reporting of flatus and discomfort 3.1.3 Medical officer prescribed chewing gum and nurse administrate it 3.2 Instruct patient to chew without swallowing the gum for 30 minutes 3.3 Observe for abnormality 3.4 Use timer for time control 3.5 Assist patient to discard chewing gum after 30 minutes 3.6 Repeat administrating chewing gum as scheduled for 3 times per day 3.7 Use stereoscope to check patients’ bowel sound hourly 3.8 Document hourly result properly, report if any abnormality 3.9 Provide call bell to patient, allow immediate report of flatus 3.10 Document date and time of first flatus 3.11 Ensure patient safety throughout procedures
4. Evaluation 4.1 Confirm patients’ bowel movement with doctors 4.2 Distributed evaluation form to patients 4.2.1 Provide instruction of filling the evaluation form 4.2.2 Allow privacy and sufficient time for filling form 4.3 Collect evaluation form for later analysis
80
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